In a 52-week clinical study, an investigational biosimilar for etanercept, SB4, showed lasting efficacy (including radiographic progression), immunogenicity and safety.1 This trial was a randomized, double-blind study in adults with moderate to severe rheumatoid arthritis (RA), despite methotrexate treatment.
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Five hundred and ninety-six patients were randomized to receive either SB4 (n=299) or Enbrel (etanercept; ETN) (n=297). The ACR20 response rate was 81% in patients who received SB4 vs. 82% in those who received ETN. Additionally, the ACR50 and ACR70 response rates were slightly higher for SB4 compared with ETN.
The safety profiles were also comparable. One treatment-emergent adverse event occurred in 59% of SB4-treated patients vs. 60% of ETN-treated patients; and injection-site reactions occurred in 4% vs. 18% of SB4- and ETN-treated patients, respectively (P<0.001). At Week 52, at least one anti-drug antibody result occurred in 1% and 13% of SB4- and ETN-treated patients, respectively (P<0.001). The serious infection, tuberculosis and malignancy rates were all comparable.
CHS-0214 is another investigational ETN biosimilar. The treatment met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study evaluating its efficacy and safety in patients with moderate to severe chronic plaque psoriasis.2 The efficacy endpoints were based on a 12-week assessment of Psoriasis Activity Severity Index (PASI) scores. The primary endpoints were the mean percent change in PASI from baseline and the proportion of patients achieving 75% improvement in PASI from baseline. These results met the pre-specified limits for demonstrating an equivalence to ETN. No clinically meaningful differences were noted in the safety profiles of the two products evaluated.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Encovsky J, Sylwestrzak A, Leszczyñski P, et al. A phase 3, randomized, double-blind clinical study comparing SB4, an etanercept biosimilar, with etanercept reference product (Enbrel) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (52-week results). Arthritis Rheumatol. 2015 Sep; 67(9, suppl 10).
- Coherus BioSciences Inc. New release: Coherus and Baxalta announce CHS-0214 (investigational etanercept biosimilar) met primary efficacy endpoints in phase 3 psoriasis clinical study (RaPsODY). 2015 Nov 10.